Respiratory Syncytial Virus (RSV) Virus disease
Conditions
Interventions
Group 1. The people in this group will get the RSVpreF vaccine.
Group 2. The people in this group will get a placebo.
Sponsors
Pfizer
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, frequent symptom assessment by mobile device application, and other study procedures, including collection of nasal swabs by themselves and by study staff when indicated. 2. Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. Specific criteria for participants with known stable infection with HIV, HCV, or HBV can be found in Section 10.8. 3. Adults who are ambulatory and live in the community, or in assisted-living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living. 4. Capable of giving signed informed consent as described in Section 10.1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. 5. Male or female participants >=60 years of age. * Male participants able to father children must agree to use a highly effective method of contraception from the time of informed consent through at least 28 days after study intervention administration (see Section 10.3.1). * Female participants must not be of childbearing potential (see Section 10.3.3).
Exclusion criteria
Exclusion criteria: 1. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 2. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine. 3. Serious chronic disorder including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator*s opinion, excludes the participant from participating in the study. 4. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 5. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator*s judgment, make the participant inappropriate for the study. 6. Participation in other studies involving study intervention within 28 days prior to consent and/or through and including the 6-month follow-up visit (Visit 3). Note: This criterion does not apply to participants who are participating in a follow-up period for another study involving a study intervention that is an investigational drug or vaccine, if receipt of the last dose was at least 12 months prior to consenting for this study and there is no further dosing anticipated from the previous study during the participant's participation in this study. 7. Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study. If systemic corticosteroids have been administered short term (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy: In participants in compliance with the key protocol criteria (evaluable efficacy population): 1. VE, defined as the relative risk reduction of first-episode LRTI-RSV cases with >=2 LRTI signs/symptoms in the RSVpreF group compared to the placebo group in the first RSV season (starting on Day 15 after study vaccination) and in compliance with the key protocol criteria (evaluable efficacy population). 2. VE, defined as the relative risk reduction of first-episode LRTI-RSV cases with >=3 LRTI signs/symptoms in the RSVpreF group compared to the placebo group in the first RSV season (starting on Day 15 after study vaccination). Primary Safety: In participants receiving study intervention: 1. The proportion of participants reporting prompted local reactions within 7 days following study intervention administration in a subset of participants. 2. The proportion of participants. reporting prompted systemic events within 7 days following study intervention administration in a subset of participants. 3. The proportion of participants reporting AEs through 1 month following study intervention administration. 4. The proportion of participants reporting NDCMCs throughout the study. 5. The proportion of participants reporting SAEs throughout the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key Secondary Efficacy: In participants in compliance with the key protocol criteria (evaluable efficacy population): VE, defined as the relative risk reduction of first- episode sLRTI-RSV cases in the RSVpreF group compared to the placebo group in the first RSV season (starting on Day 15 after study vaccination). Secondary Efficacy: In participants in compliance with the key protocol criteria (evaluable efficacy population): - VE, defined as the relative risk reduction of first-episode LRTI-RSV cases with >=2 LRTI signs/symptoms in the RSVpreF group compared to the placebo group: • starting on Day 15 after study vaccination through 2 RSV seasons. • starting on Day 15 after study vaccination through 3 RSV seasons. VE, defined as the relative risk reduction of first- episode LRTI-RSV cases with >=3 LRTI signs/symptoms in the RSVpreF group compared to the placebo group • starting on Day 15 after study vaccination through 2 RSV seasons. • starting on Day 15 after study vaccination through 3 RSV seasons. In participants in compliance with the key protocol criteria (evaluable efficacy population): • VE, defined as the relative risk reduction of first-episode LRTI-RSV cases with >=2 LRTI signs/symptoms in the RSVpreF group compared to the placebo group, in the second RSV season and in the third RSV season. • VE, defined as the relative risk reduction of first-episode LRTI-RSV cases with >=3 LRTI signs/symptoms in the RSVpreF group compared to the placebo group, in the second RSV season and in the third RSV season. In participants in compliance with the key protocol criteria (evaluable efficacy population): - VE, defined as the relative risk reduction of first-episode ARI-RSV cases in the RSVpreF group compared to the placebo group: • in the first RSV season (from Day 15), in the second RSV season, and in the third RSV season. • starting on Day 15 after study vaccination through the first 2 RSV seasons, and through all 3 RSV seasons,. In pa | — |
Countries
Netherlands
Outcome results
None listed